• DIN EN 14254 E : 2004

    Current The latest, up-to-date edition.

    IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2004

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials
    5 Nominal liquid capacity
    6 Graduation and fill lines
       6.1 Graduation lines
       6.2 Minimum fill line
       6.3 Maximum fill line
    7 Design
    8 Construction
    9 Sterility and special microbiological states
    10 Additives
    11 Information supplied by the manufacturer
    Annex A (normative) Tests for nominal capacity, graduation
                        lines and minimum free space for
                        non-evacuated specimen receptacles up
                        to and including 30 ml nominal capacity
       A.1 Reagents and apparatus
       A.2 Test Conditions
       A.3 Test procedure
    Annex B (normative) Tests for nominal capacity, graduation
                        lines and minimum free space, for
                        non-evacuated specimen receptacles of
                        greater than 30 ml nominal capacity
       B.1 Reagents and apparatus
       B.2 Test conditions
       B.3 Test procedures
    Annex C (normative) Tests for draw volume and minimum free
                        space for evacuated receptacles
       C.1 Reagents and apparatus
       C.2 Test conditions
       C.3 Test procedure
    Annex D (normative) Test for leakage from the closure of
                        a receptacle
       D.1 Reagents and apparatus
       D.2 Test procedure for non-evacuated receptacles intended
           for storage above 0 degree C
       D.3 Test procedure for non-evacuated receptacles intended
           for storage at 0 degree C or below
       D.4 Test procedure for evacuated receptacles
    Annex E (normative) Test for the robustness of a receptacle
                        that is intended for centrifugation
       E.1 Reagents and apparatus
       E.2 Test conditions
       E.3 Test procedure
    Annex ZA (informative) Relationship between this European
                           Standard and the Essential
                           Requirements of EU Directive 98/79/EC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    ISO 4788:2005 Laboratory glassware Graduated measuring cylinders
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
    EN 829 : 1996 IN VITRO DIAGNOSTIC SYSTEMS - TRANSPORT PACKAGES FOR MEDICAL AND BIOLOGICAL SPECIMENS - REQUIREMENTS, TESTS
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN 14820:2004 Single-use containers for human venous blood specimen collection
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective